Enforcement Report - Week of October 17, 2012

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Product Detail

Product Description

IDS-iSYS N-Mid® Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles.
The IDS-iSYS N-Mid® Osteocalcin Assay is intended for the quantitative determination of Osteocalcin in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to assist the clinician. Osteocalcin is an indicator of osteoblastic activity in human serum and plasma and is intended to be used as an aid in the prevention of osteoporosis.

Recall Number

Z-0042-2013

Classification

Class II

Code Info

Lot 948 and 1145, EXP Aug 2012 and Jan 2013 respectively

Product Distributed Qty

5

Reason For Recall

It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.